Newsletters
Table of contents
The European Medicines Agency (EMA) publishes newsletters to provide updates on various topics to patients, healthcare professionals and the pharmaceutical industry.
Human medicines highlights, published monthly, contains key information on human medicines and changes to regulatory processes in the past month. These highlights do not cover all the Agency's activities in the area of human medicines.
EMA provides an RSS feed of the human medicines highlights. To subscribe, use the below link and follow our user guide on how to subscribe to RSS feeds:
EMA does not collect any personal data from you when you subscribe to this RSS feed.
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Human medicines highlights - October 2023 (PDF/329.23 KB)
First published: 11/10/2023 -
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Human medicines highlights - September 2023 (PDF/274.2 KB)
First published: 11/09/2023
Issue 173 -
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Human medicines highlights - August 2023 (PDF/285.65 KB)
First published: 14/08/2023
Issue 172 -
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Human medicines highlights - June 2023 (PDF/305.45 KB)
First published: 16/06/2023
Issue 170 -
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Human medicines highlights - May 2023 (PDF/371.05 KB)
First published: 11/05/2023
Issue 169 -
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Human medicines highlights - April 2023 (PDF/356.44 KB)
First published: 12/04/2023
Issue 168 -
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Human medicines highlights - March 2023 (PDF/340.59 KB)
First published: 09/03/2023
Issue 167 -
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Human medicines highlights - February 2023 (PDF/273.8 KB)
First published: 06/02/2023
Issue 166 -
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Human medicines highlights - January 2023 (PDF/339.17 KB)
First published: 11/01/2023
Last updated: 18/01/2023
Issue 165 -
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Human medicines highlights - December 2022 (PDF/342.63 KB)
First published: 13/12/2022
Issue 164 -
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Human medicines highlights - November 2022 (PDF/284.79 KB)
First published: 14/11/2022
Issue 163 -
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Human medicines highlights - September 2022 (PDF/449.35 KB)
First published: 12/10/2022
Issue 162 -
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Human medicines highlights - August 2022 (PDF/347.93 KB)
First published: 08/08/2022
Issue 161 -
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Human medicines highlights - July 2022 (PDF/274.83 KB)
First published: 18/07/2022
Isssue 160 -
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Human medicines highlights - June 2022 (PDF/278.67 KB)
First published: 08/06/2022
Isssue 159 -
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Human medicines highlights - April 2022 (PDF/262.57 KB)
First published: 11/04/2022
Isssue 157 -
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Human medicines highlights - March 2022 (PDF/336.87 KB)
First published: 07/03/2022
Issue 156 -
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Human medicines highlights - February 2022 (PDF/277.2 KB)
First published: 04/02/2022
Issue 155 -
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Human medicines highlights - January 2022 (PDF/282.14 KB)
First published: 14/01/2022
Issue 154 -
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Human medicines highlights - December 2021 (PDF/279.74 KB)
First published: 06/12/2021
Issue 153 -
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Human medicines highlights - November 2021 (PDF/333.27 KB)
First published: 11/11/2021
Issue 152 -
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Human medicines highlights - October 2021 (PDF/336.35 KB)
First published: 07/10/2021
Issue 151 -
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Human medicines highlights - September 2021 (PDF/239.43 KB)
First published: 07/09/2021
Issue 150 -
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Human medicines highlights - August 2021 (PDF/330.45 KB)
First published: 05/08/2021
Issue 149 -
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Human medicines highlights - July 2021 (PDF/385.37 KB)
First published: 06/07/2021
Issue 148 -
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Human medicines highlights - June 2021 (PDF/399.25 KB)
First published: 04/06/2021
Issue 147 -
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Human medicines highlights - May 2021 (PDF/329.31 KB)
First published: 31/05/2021
Issue 146 -
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Human medicines highlights - April 2021 (PDF/481.79 KB)
First published: 14/04/2021
Issue 145 -
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Human medicines highlights - March 2021 (PDF/272.14 KB)
First published: 18/03/2021
Issue 144 -
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Human medicines highlights - February 2021 (PDF/453.49 KB)
First published: 03/02/2021
Issue 143 -
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Human medicines highlights - January 2021 (PDF/872.45 KB)
First published: 13/01/2021
Issue 142 -
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Human medicines highlights - December 2020 (PDF/774.63 KB)
First published: 10/12/2020
Issue 141 -
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Human medicines highlights - November 2020 (PDF/628.62 KB)
First published: 11/11/2020
Issue 140 -
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Human medicines highlights - October 2020 (PDF/674.99 KB)
First published: 12/10/2020
Issue 139 -
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Human medicines highlights - September 2020 (PDF/333.09 KB)
First published: 04/09/2020
Issue 138 -
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Human medicines highlights - August 2020 (PDF/621.19 KB)
First published: 07/08/2020
Issue 137 -
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Human medicines highlights - July 2020 (PDF/810.96 KB)
First published: 09/07/2020
Issue 136 -
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Human medicines highlights - June 2020 (PDF/606.29 KB)
First published: 08/06/2020
Issue 135 -
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Human medicines highlights - May 2020 (PDF/352.37 KB)
First published: 11/05/2020
Issue 134 -
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Human medicines highlights - April 2020 (PDF/282.67 KB)
First published: 14/04/2020
Issue 133 -
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Human medicines highlights - March 2020 (PDF/812.12 KB)
First published: 11/03/2020
Issue 132 -
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Human medicines highlights - February 2020 (PDF/488.32 KB)
First published: 10/02/2020
Issue 131 -
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Human medicines highlights - January 2020 (PDF/654.41 KB)
First published: 17/01/2020
Issue 130 -
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Human medicines highlights - December 2019 (PDF/442.81 KB)
First published: 10/12/2019
Issue 129 -
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Human medicines highlights - November 2019 (PDF/335.94 KB)
First published: 07/11/2019
Issue 128 -
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Human medicines highlights - October 2019 (PDF/355.34 KB)
First published: 07/10/2019
Issue 127 -
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Human medicines highlights - September 2019 (PDF/339.4 KB)
First published: 11/09/2019
Issue 126 -
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Human medicines highlights - August 2019 (PDF/396.97 KB)
First published: 13/08/2019
Issue 125 -
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Human medicines highlights - July 2019 (PDF/419.77 KB)
First published: 05/07/2019
Last updated: 24/07/2019
Issue 124 -
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Human medicines highlights - June 2019 (PDF/352.18 KB)
First published: 06/06/2019
Issue 123 -
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Human medicines highlights - May 2019 (PDF/337.41 KB)
First published: 10/05/2019
Issue 122 -
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Human medicines highlights - April 2019 (PDF/372.19 KB)
First published: 12/04/2019
Issue 121 -
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Human medicines highlights - March 2019 (PDF/452.59 KB)
First published: 06/03/2019
Issue 120 -
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Human medicines highlights - February 2019 (PDF/389.08 KB)
First published: 13/02/2019
Issue 119 -
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Human medicines highlights - January 2019 (PDF/378.06 KB)
First published: 14/01/2019
Issue 118
The newsletter for micro-, small- and medium-sized enterprises (SMEs), published four times a year, provides key updates to SMEs on the European regulatory environment.
For older editions, see the Newsletter archive.
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News bulletin for small and medium-sized enterprises - Issue 60 (PDF/1.33 MB) (new)
First published: 20/11/2023 -
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News bulletin for small and medium-sized enterprises - Issue 59 (PDF/1.09 MB)
First published: 26/07/2023 -
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News bulletin for small and medium-sized enterprises - Issue 58 (PDF/1.05 MB)
First published: 28/04/2023
Issue 58 -
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News bulletin for small and medium-sized enterprises - Issue 57 (PDF/1.04 MB)
First published: 12/01/2023
Issue 57 -
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News bulletin for small and medium-sized enterprises - Issue 56 (PDF/1.17 MB)
First published: 02/08/2022
Issue 56 -
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News bulletin for small and medium-sized enterprises - Issue 55 (PDF/1.28 MB)
First published: 17/05/2022
Issue 55 -
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News bulletin for small and medium-sized enterprises - Issue 54 (PDF/1.08 MB)
First published: 14/12/2021
Issue 54 -
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News bulletin for small and medium-sized enterprises - Issue 53 (PDF/1.59 MB)
First published: 29/07/2021
Issue 53 -
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News bulletin for small and medium-sized enterprises - Issue 52 (PDF/1.13 MB)
First published: 19/04/2021
Issue 52 -
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News bulletin for small and medium-sized enterprises - Issue 51 (PDF/1.32 MB)
First published: 19/01/2021
Issue 51 -
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News bulletin for small and medium-sized enterprises - Issue 50 (PDF/537.38 KB)
First published: 10/09/2020
Issue 50 -
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News bulletin for small and medium-sized enterprises - Issue 49 (PDF/632.66 KB)
First published: 07/05/2020
Issue 49 -
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News bulletin for small and medium-sized enterprises - Issue 48 (PDF/643.01 KB)
First published: 29/01/2020
Issue 48 -
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News bulletin for small and medium-sized enterprises - Issue 47 (PDF/687.64 KB)
First published: 26/08/2019
Issue 47 -
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News bulletin for small and medium-sized enterprises - Issue 46 (PDF/1.09 MB)
First published: 08/03/2019
Issue 46 -
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News bulletin for small and medium-sized enterprises - Issue 45 (PDF/1016.05 KB)
First published: 23/11/2018
Issue 45 -
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News bulletin for small and medium-sized enterprises - Issue 44 (PDF/580.16 KB)
First published: 09/08/2018
Last updated: 09/08/2018
Issue 44 -
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News bulletin for small and medium-sized enterprises - Issue 43 (PDF/779.53 KB)
First published: 14/05/2018
Last updated: 14/05/2018 -
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News bulletin for small and medium-sized enterprises - Issue 42 (PDF/1.35 MB)
First published: 06/02/2018
Last updated: 06/02/2018
Issue 42 -
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News bulletin for small and medium-sized enterprises - Issue 41 (PDF/796.64 KB)
First published: 07/11/2017
Last updated: 07/11/2017 -
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News bulletin for small and medium-sized enterprises - Issue 40 (PDF/1007.65 KB)
First published: 27/07/2017
Last updated: 27/07/2017 -
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News bulletin for small and medium-sized enterprises - Issue 39 (PDF/765.33 KB)
First published: 16/05/2017
Last updated: 16/05/2017
Issue 39 -
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News bulletin for small and medium-sized enterprises - Issue 38 (PDF/771.39 KB)
First published: 02/02/2017
Last updated: 02/02/2017 -
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News bulletin for small and medium-sized enterprises - Issue 37 (PDF/488.74 KB)
First published: 27/10/2016
Last updated: 27/10/2016
Issue 37 -
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News bulletin for small and medium-sized enterprises - Issue 36 (PDF/846.46 KB)
First published: 03/08/2016
Last updated: 03/08/2016
Issue 36 -
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News bulletin for small and medium-sized enterprises - Issue 35 (PDF/802.95 KB)
First published: 29/04/2016
Last updated: 29/04/2016 -
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News bulletin for small and medium-sized enterprises - Issue 34 (PDF/597.34 KB)
First published: 25/01/2016
Last updated: 25/01/2016
Issue 34 -
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News bulletin for small and medium-sized enterprises - Issue 33 (PDF/807.15 KB)
First published: 20/10/2015
Last updated: 20/10/2015
Issue 33 -
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News bulletin for small and medium-sized enterprises - Issue 32 (PDF/412.12 KB)
First published: 30/07/2015
Last updated: 30/07/2015
Issue 32 -
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News bulletin for small and medium-sized enterprises - Issue 31 (PDF/645.42 KB)
First published: 15/04/2015
Last updated: 15/04/2015
Issue 31 -
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News bulletin for small and medium-sized enterprises - Issue 30 (PDF/559.72 KB)
First published: 28/01/2015
Last updated: 28/01/2015
Issue 30
What's new in pharmacovigilance, published four times a year, updates qualified persons for pharmacovigilance on guidance, regulations and events.
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What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2019 (PDF/384.21 KB)
First published: 09/08/2019
Issue 1 - 2019 -
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What’s new in pharmacovigilance - QPPV Update - Issue 2 - 2018 (PDF/342.24 KB)
First published: 07/01/2019
Issue 2 -
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What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2018 (PDF/373.34 KB)
First published: 31/07/2018
Last updated: 31/07/2018
Issue 1 -
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What's new in pharmacovigilance - QPPV Update - Issue 3 - 2017 (PDF/359.44 KB)
First published: 21/12/2017
Last updated: 21/12/2017
Issue 3 - 2017 -
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What's new in pharmacovigilance - QPPV Update - Issue 2 - 2017 (PDF/591.05 KB)
First published: 09/08/2017
Last updated: 09/08/2017 -
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What's new in pharmacovigilance - QPPV Update - Issue 1 - 2017 (PDF/431.62 KB)
First published: 11/04/2017
Last updated: 11/04/2017
Issue 1 - 2017 -
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What's new in pharmacovigilance - QPPV Update - Issue 3 (PDF/562.97 KB)
First published: 22/12/2016
Last updated: 22/12/2016
Issue 3 -
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What's new in pharmacovigilance - QPPV Update - Issue 2 (PDF/594.24 KB)
First published: 09/08/2016
Last updated: 09/08/2016
Issue 2 -
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What's new in pharmacovigilance - QPPV Update - Issue 1 (PDF/609.89 KB)
First published: 29/04/2016
Last updated: 29/04/2016
Issue 1 -
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News bulletin for pharmacovigilance programme update - Issue 6 (PDF/456.55 KB)
First published: 21/12/2015
Last updated: 21/12/2015
Issue 6 -
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News bulletin for pharmacovigilance programme update - Issue 5 (PDF/514.54 KB)
First published: 13/10/2015
Last updated: 13/10/2015
Issue 5 -
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News bulletin for pharmacovigilance programme update - Issue 4 (PDF/657.06 KB)
First published: 03/07/2015
Last updated: 03/07/2015
Issue 4 -
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News bulletin for pharmacovigilance programme update - Issue 3 (PDF/488.45 KB)
First published: 31/03/2015
Last updated: 31/03/2015
Issue 3
EMA's ‘CTIS newsflash’ contains key updates on the latest developments, including system improvements, and links to useful reference materials.
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CTIS newsflash – 10 November 2023 (PDF/629.21 KB) (new)
First published: 10/11/2023
EMA/486111/2023 -
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CTIS newsflash – 27 October 2023 (PDF/587.53 KB)
First published: 30/10/2023
EMA/471461/2023 -
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CTIS newsflash – 13 October 2023 (PDF/633.66 KB)
First published: 30/10/2023
EMA/440825/2023 -
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CTIS newsflash - 29 September 2023 (PDF/573.26 KB)
First published: 02/10/2023
EMA/416454/2023 -
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CTIS newsflash - 15 September 2023 (PDF/665.42 KB)
First published: 15/09/2023
EMA/397022/2023 -
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CTIS newsflash - 1 September 2023 (PDF/455.49 KB)
First published: 04/09/2023
EMA/376569/2023 -
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CTIS newsflash – 18 August 2023 (PDF/748.6 KB)
First published: 18/08/2023
EMA/356297/2023 -
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CTIS newsflash - 4 August 2023 (PDF/575.83 KB)
First published: 04/08/2023
EMA/339073/2023 -
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CTIS newsflash - 21 July 2023 (PDF/615.79 KB)
First published: 24/07/2023
EMA/293653/2023 -
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CTIS newsflash - 7 July 2023 (PDF/866.26 KB)
First published: 12/07/2023
EMA/293590/2023 -
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CTIS newsflash – 23 June 2023 (PDF/747.99 KB)
First published: 05/07/2023 -
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CTIS newsflash - 9 June 2023 (PDF/698.43 KB)
First published: 12/06/2023
EMA/231823/2023 -
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CTIS newsflash - 26 May 2023 (PDF/498.48 KB)
First published: 30/05/2023
EMA/220482/2023 -
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CTIS newsflash - 12 May 2023 (PDF/438.13 KB)
First published: 16/05/2023
EMA/209485/2023 -
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CTIS newsflash - 5 May 2023 (PDF/556.16 KB)
First published: 08/05/2023
EMA/186032/2023 -
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CTIS newsflash - 28 April 2023 (PDF/478.03 KB)
First published: 28/04/2023
EMA/184144/2023 -
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CTIS newsflash - 21 April 2023 (PDF/446.23 KB)
First published: 24/04/2023
EMA/171343/2023 -
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CTIS newsflash - 14 April 2023 (PDF/486.34 KB)
First published: 14/04/2023
EMA/155249/2023 -
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CTIS newsflash – 31 March 2023 (PDF/720.22 KB)
First published: 31/03/2023
EMA/141792/2023 -
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CTIS newsflash – 24 March 2023 (PDF/648.83 KB)
First published: 27/03/2023
EMA/127714/2023 -
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CTIS newsflash – 17 March 2023 (PDF/693.91 KB)
First published: 17/03/2023
EMA/114900/2023 -
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CTIS newsflash - 10 March 2023 (PDF/446.06 KB)
First published: 10/03/2023
EMA/103161/2023 -
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CTIS newsflash - 3 March 2023 (PDF/455.83 KB)
First published: 03/03/2023
EMA/89888/2023 -
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CTIS newsflash - 24 February 2023 (PDF/450.06 KB)
First published: 27/02/2023
EMA/78479/2023 -
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CTIS newsflash - 17 February 2023 (PDF/427.99 KB)
First published: 20/02/2023
EMA/69125/2023 -
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CTIS newsflash - 10 February 2023 (PDF/494.95 KB)
First published: 13/02/2023
EMA/58602/2023 -
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CTIS newsflash - 3 February 2023 (PDF/138.1 KB)
First published: 03/02/2023
EMA/47266/2023 -
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CTIS newsflash - 27 January 2023 (PDF/135.5 KB)
First published: 31/01/2023
EMA/36776/2023 -
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CTIS newsflash – 20 January 2023 (PDF/315.43 KB)
First published: 23/01/2023
EMA/23426/2023 -
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CTIS newsflash – 13 January 2023 (PDF/130.75 KB)
First published: 13/01/2023
EMA/6441/2023 -
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CTIS newsflash - 6 January 2023 (PDF/146.13 KB)
First published: 09/01/2023
EMA/957698/2022 -
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CTIS newsflash - 22 December 2022 (PDF/117.45 KB)
First published: 05/01/2023
EMA/940077/2022 -
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CTIS newsflash - 12 December 2022 (PDF/138.36 KB)
First published: 22/12/2022 -
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CTIS newsflash - 5 December 2022 (PDF/146.31 KB)
First published: 22/12/2022 -
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CTIS newsflash - 22 April 2022 (PDF/117.57 KB)
First published: 25/04/2022 -
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CTIS newsflash - 8 April 2022 (PDF/120.71 KB)
First published: 11/04/2022 -
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CTIS newsflash - 1 April 2022 (PDF/118.91 KB)
First published: 05/04/2022
EMA/193739/2022 -
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CTIS newsflash - 25 March 2022 (PDF/134.03 KB)
First published: 28/03/2022
EMA/183329/2022 -
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CTIS newsflash - 18 March 2022 (PDF/131.93 KB)
First published: 21/03/2022
EMA/168795/2022 -
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CTIS newsflash - 11 March 2022 (PDF/138.49 KB)
First published: 14/03/2022
EMA/149078/2022 -
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CTIS newsflash - 4 March 2022 (PDF/150.3 KB)
First published: 08/03/2022
EMA/131960/2022 -
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CTIS newsflash - 25 February 2022 (PDF/123 KB)
First published: 01/03/2022
EMA/119802/2022 -
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CTIS newsflash - 18 February 2022 (PDF/122.89 KB)
First published: 23/02/2022
EMA/104967/2022 -
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CTIS newsflash - 11 February 2022 (PDF/117.93 KB)
First published: 15/02/2022
EMA/83300/2022 -
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CTIS newsflash - 4 February 2022 (PDF/122.42 KB)
First published: 07/02/2022
EMA/70002/2022
Issues from July 2023 (Issue 15) onwards are available at the link below:
Previous issues are available on EMA's website in PDF format:
Issues from September 2023 (Issue 13) onwards are available at the link below:
Previous issues are available on EMA's website in PDF format:
Issues from June 2023 (Issue 6) onwards are available at the link below:
• Big Data Highlights: Issue 6 onwards
Previous issues from 2022 are available on EMA's website in PDF format:
The electronic Application Form (eAF) - Product Management Service (PMS) newsletter provides pharmaceutical companies and national competent authorities in the EU updates on the progress of the eAF and PMS products. It also includes an overview of upcoming events and information on available resources.
The objective of the eAF product is to replace PDF eAFs used for regulatory submissions with online forms available on the Product Lifecycle Management (PLM) Portal, in order to make completing and handling applications more efficient.
For more information, see:
The Product Management Service (PMS) makes available comprehensive and consolidated data on centrally authorised products (CAPs) and non-centrally authorised products (non-CAPs) from different sources across the European Medicines Regulatory Network.
The data can be re-used in electronic applications and throughout regulatory processes.
For more information, see:
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Electronic Application Form (eAF) - Product Management Service (PMS) newsletter - Issue 3 (PDF/1.34 MB)
First published: 15/05/2023
Issue 3 -
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Electronic Application Form (eAF) newsletter - Issue 2 (PDF/717.9 KB)
First published: 21/12/2022
Last updated: 10/01/2023
Issue 2 -
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Digital Application Dataset Integration (DADI) newsletter - Issue 1 (PDF/548.17 KB)
First published: 26/07/2022
Issue 1